OTC Medication Information: HAND SANITIZER

HAND SANITIZER- alcohol liquid
Absara Cosmetics S.A.P.I DE C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Alcohol 80% v/v

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable.

Keep away from heat or flame.

Do not use

In children less than 2 months of age.
On open skin wounds.

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces.
Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Glycerin, hydrogen peroxide, purified water USP.

Questions or Comments?

1-800-615-3191 cloralen@alenusa.com, or visit: www.cloralen.com

DISTRIBUTED BY:
ALEN USA
Houston, TX
77040 USA

PRINCIPAL DISPLAY PANEL — 60 mL Bottle Label

LIQUID HAND SANITIZER

CLORALEN
HAND SANITIZER

ALCOHOL
ANTISEPTIC
80%

TOPICAL
SOLUTION

NON
STERILE
SOLUTION

2.03 FL OZ (60 mL)

TRAVEL SIZE

Principal Display Panel -- 60 mL Bottle Label
(click image for full-size original)
HAND SANITIZER
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70956-013
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (Alcohol) Alcohol 80 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
HYDROGEN PEROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70956-013-01 60 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333A 06/09/2020
Labeler — Absara Cosmetics S.A.P.I DE C.V. (816161236)
Establishment
Name Address ID/FEI Operations
Absara Cosmetics S.A.P.I DE C.V. 816161236 MANUFACTURE (70956-013)

Revised: 06/2020 Absara Cosmetics S.A.P.I DE C.V.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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